MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC EDWARDS TRANSFEMORAL BALLOON CATHETER; BALLOON AORTIC VALVULOPLASTY

Model Number 9350BC25

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Ventricular Fibrillation (2130)

Event Date 05/30/2022

Event Type  Injury  

Manufacturer Narrative

Per the instructions for use (ifu), arrhythmias are known potential adverse events associated with balloon valvuloplasty, the use of local and/or general anesthesia, aortic valve replacement and the overall tavr procedure.Peri-procedural ventricular arrhythmias can be associated with patient and procedural factors such as poor ventricular function, inadequate coronary perfusion, hypovolemia, annular rupture/ aortic dissection, cardiac tamponade, wire and catheter manipulation and prolonged or repetitive runs of rapid pacing.These patients can be non-operative or high risk, have complex medical histories and multiple co-morbidities.They are routinely administered multiple vasoactive drugs during the procedure and are intentionally made hypotensive, utilizing rapid ventricular pacing, to facilitate accurate valve deployment.As a result of these factors, intra-operative arrhythmias and hypotension are not uncommon and are treated with standard therapies, including additional vasoactive drugs or electrical conversion.It is also not uncommon to initiate brief chest compressions or cardiac massage to facilitate distribution of these vasoactive drugs.If these standard maneuvers are not adequate, initiation of cardiopulmonary bypass (cpb), insertion of iabp, and/or conversion to open surgery may be required.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.The cause of the heart block cannot be confirmed, however, may be related to patient factors and/or the mechanisms described above.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required at this time.

Event Description

As reported, it was a case of an implant of 29mm edwards sapien 3 transcatheter heart valve.After performing balloon predilatation the patient was immediately hemodynamically unstable, possible to acute severe aortic regurgitation and the development of ventricular fibrillation.A sapien 29mm valve was then successfully implanted under active reanimation with a control angiography showing good valve position and lack of pvl or coronary obstruction.The patient's deteriorating hemodynamic condition necessitated ecmo support and multiple cardioversion attempts.The patient was stabilized, however during insertion of the ecmo sheath an iatrogenic dissection of the descending aorta occurred with a follow-up tee and angiography documenting retrograde progression of the dissection into the ascending segment , but no compromise of the coronary circulation.The ecmo was later removed and the patient was transferred to the intensive care unit , intubated in a stable hemodynamic condition.Patient passed away on pod 5.

• Brand Name: EDWARDS TRANSFEMORAL BALLOON CATHETER
• Type of Device: BALLOON AORTIC VALVULOPLASTY
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 14778376
• MDR Text Key: 294538473
• Report Number: 2015691-2022-06332
• Device Sequence Number: 1
• Product Code: OZT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K140241
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2023
• Device Model Number: 9350BC25
• Device Catalogue Number: N/A
• Device Lot Number: 64143065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male